Senior Principal Scientist, Quantitative Pharmacology and Pharmacometrics (R6)
This Senior Principal Scientist (Senior Director equivalent) role is intended to provide scientific leadership for the discovery and development of internal assets in the immunology therapeutic area and provide scientific input on the evaluation of external assets. The ideal candidate should have a deep subject matter expertise in immunology either in the discovery/translational space and/or has been directly engaged in the development or registration of clinical autoimmune programs.
Senior Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) oversee and directly apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications.
Senior Principal Scientists provide strategic leadership and oversight, both supervising the work of other scientists and leading QP2 efforts on drug development programs and on business development efforts. Senior Principal Scientists are expected to have or be developing expertise in several areas, including:
Overseeing a suite of programs (including both program strategy and execution) across the immunology portfolio
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, contributing to cross-functional regulatory strategy, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
Serving as an expert representative for QP2 on drug development teams and in cross-functional and governance discussions, including business development and licensing evaluations
Framing critical drug development questions for optimizing model-based development population pharmacokinetic, exposure-response, quantitative system pharmacology (QSP) and disease progression models
Driving the development of mechanistic, disease progression and comparator modeling platforms to help drive portfolio decisions
Influencing clinical trial design via trial simulations and comparator modeling
Mentoring and/or supervising colleagues to perform the above duties and to develop the above capabilities
The Senior Principal Scientist is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic and regulatory elements of drug development. She/he develops strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs. In addition to the responsibilities described above, Senior Principal Scientists demonstrate outstanding leadership and communication skills, collaborating across QP2 and with other functional areas, as well as with external vendors and partners to create a quantitative model-informed approach to impact program strategies and decision making on drug development teams.
(a Ph.D. or equivalent degree with at least 10 years of experience) OR (a PharmD or equivalent degree with at least 12 years of experience) OR (an MS or equivalent degree with at least 14 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field
Deep subject matter expertise in immunology either in the discovery/translational space and/or has been directly engaged in the development or registration of clinical autoimmune programs
Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists
Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, Phoenix, etc.)
Scientific understanding of biopharmaceutical and ADME properties of both small molecules and biologics
Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$173,900.00 - $295,700.00
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Flexible Work Arrangements:Hybrid
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Number of Openings:1